DEVICE: MedGyn Flexible/Karman Cannula-Curette 11mm (M803K022011)

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Device Record History
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Device Identifier (DI) Information
MedGyn Flexible/Karman Cannula-Curette 11mm
11mm Flexible/Karman Curette
In Commercial Distribution
022011K
MedGyn Products, Inc.
M803K022011
HIBCC

1
103913430 *Terms of Use
11mm Flexible/Karman Curette
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Device Characteristics
MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32655 Intrauterine cannula, single-use
A sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HCY Curette, Uterine
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
a4c59331-7101-47cb-989a-91c160c1fdcf
June 29, 2026
2
April 17, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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